Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2026-01-02 @ 12:34 PM
Study NCT ID:
NCT02475603
Status:
UNKNOWN
Last Update Posted:
2015-06-19
First Post:
2015-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical, Biochemical and Neurophysiological Consequences of Intraoperative Tourniquet During Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019645', 'term': 'Arthroplasty, Replacement, Knee'}], 'ancestors': [{'id': 'D019643', 'term': 'Arthroplasty, Replacement'}, {'id': 'D001178', 'term': 'Arthroplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-06-15', 'studyFirstSubmitDate': '2015-06-10', 'studyFirstSubmitQcDate': '2015-06-15', 'lastUpdatePostDateStruct': {'date': '2015-06-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biochemical Data', 'timeFrame': 'During operation 60 min Ischemia/Shame-Ischemia Time', 'description': 'Measurement of intracellular proteolytic activity'}], 'secondaryOutcomes': [{'measure': 'Bloodloss', 'timeFrame': '1 week postoperative'}, {'measure': 'Complications', 'timeFrame': '6 months postoperative'}, {'measure': 'Clinical Scores', 'timeFrame': '6 months postoperative', 'description': 'WOMAC-Score, Knee-Score'}, {'measure': 'Radiographic Scores', 'timeFrame': '1 Week postoperative', 'description': 'Prosthesis Position on radiographs'}, {'measure': 'Electrophysiological Evaluation of the N. femoralis', 'timeFrame': '1 Week postoperative', 'description': 'Nerve function analysis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Muscles Ischemia']}, 'referencesModule': {'references': [{'pmid': '25219028', 'type': 'BACKGROUND', 'citation': 'Girard N. Evidence appraisal of Zhang W, Li N, Chen S, Tan Y, Al-Aidaros M, Chen L. The effects of a tourniquet used in total knee arthroplasty: a meta-analysis. J Orthop Surg Res. 2014;9(1):13. http://www.josr-online.com/content/9/1/13. Accessed May 30, 2014. AORN J. 2014 Aug;100(2):224-8. doi: 10.1016/j.aorn.2014.06.003. No abstract available.'}, {'pmid': '31372679', 'type': 'DERIVED', 'citation': 'Jawhar A, Skeirek D, Stetzelberger V, Kollowa K, Obertacke U. No effect of tourniquet in primary total knee arthroplasty on muscle strength, functional outcome, patient satisfaction and health status: a randomized clinical trial. Knee Surg Sports Traumatol Arthrosc. 2020 Apr;28(4):1045-1054. doi: 10.1007/s00167-019-05646-5. Epub 2019 Aug 1.'}]}, 'descriptionModule': {'briefSummary': 'Clinical, Biochemical and Neurophysiological Consequences of Intraoperative Tourniquet During Total Knee Arthroplasty:\n\nWOMAC-Score Knee-Score Radiographic Evaluations and Scoring System Biochemical muscle biopsy analysis', 'detailedDescription': 'Biochemistry: Analysis of the muscles biopsies Clinical: Bloodloss, Complications, WOMAC-Score, Knee-Score Radiographics: Evaluations and Scoring System Neurophysiology Evaluation of N. femoralis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age = 55-85 years\n* Osteoarthritis of knee joint (degree III or IV)\n* Physical status (ASA I or II)\n* Body mass index \\< 45 kg/m²\n* Written informed consent\n\nExclusion Criteria:\n\n* Age \\<55 or \\> 85years\n* Osteoarthritis knee joint (degree I or II)\n* Physical status (ASA III or IV)\n* Body mass index ≥ 45 kg/m²\n* Unable to provide written consent\n* Malignant disease\n* Rheumatoid disease\n* Infectious disease\n* Coagulation disorder\n* History of deep vein thrombosis or pulmonary embolism\n* Peripheral arterial disease\n* Immune deficiency\n* Medication (Glucocorticoid, Aspirin, Heparin, Cumardine, Wafarin)\n* Neurological dysfunction\n* Liver insufficiency\n* Coronary heart disease\n* Immobility'}, 'identificationModule': {'nctId': 'NCT02475603', 'briefTitle': 'Clinical, Biochemical and Neurophysiological Consequences of Intraoperative Tourniquet During Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsmedizin Mannheim'}, 'officialTitle': 'Clinical, Biochemical and Neurophysiological Consequences of Intraoperative', 'orgStudyIdInfo': {'id': '2012-334N-MA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'tourniquet', 'description': 'Total knee arthroplasty will be performed with tourniquet', 'interventionNames': ['Procedure: Total knee arthroplasty']}, {'type': 'EXPERIMENTAL', 'label': 'non-tourniquet', 'description': 'Total knee arthroplasty will be performed without tourniquet', 'interventionNames': ['Procedure: Total knee arthroplasty']}], 'interventions': [{'name': 'Total knee arthroplasty', 'type': 'PROCEDURE', 'description': 'Total knee arthroplasty', 'armGroupLabels': ['non-tourniquet', 'tourniquet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68167', 'city': 'Mannheim', 'state': 'Badenwürtemberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Ahmed Jawhar, Dr.', 'role': 'CONTACT', 'email': 'jawhar_ahmed@yahoo.de'}], 'facility': 'UMM', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}], 'centralContacts': [{'name': 'Ahmed Jawhar, Dr', 'role': 'CONTACT', 'email': 'jawhar_ahmed@yahoo.de', 'phone': '0621-3834500', 'phoneExt': 'umm'}], 'overallOfficials': [{'name': 'Udo Obertacke, Prof. Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UMM'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsmedizin Mannheim', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Dr. Ahmed Jawhar', 'investigatorAffiliation': 'Universitätsmedizin Mannheim'}}}}